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Program & Rules Update Spring 2018
Producers
Micro Tier Processing (845‐025‐2025)
Micro Tier producers can apply for a concentrate endorsement and make limited concentrates under their producer license.
Immature Canopy (845‐025‐2040 & 845‐025‐2045)
Beginning April 1, 2018:
Producers will have a limit to their immature canopy, unless they apply for the propagation endorsement.
Producers can only have up to 20 canopy areas on the licensed premises.
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Producers
Production of Marijuana for Patients (845‐025‐2500 & 845‐025‐2550)
An OLCC licensed producer may submit a form to produce medically designated plants at their producer premises:
• The production area can be 10% of the total tier size• 75% of the annual yield are required to be given to patients or caregivers.
• 25% of the annual yield can be transferred or sold to OLCC processors, wholesalers or retailers.
Producers
Start‐up Inventory (845‐025‐2060)
In April the OLCC opened rulemaking to address the expiration of the start‐up inventory rule.
OLCC will be holding a rules advisory committee, public hearings and will also be receiving feedback through written public comment.
3
Processors
Processing for Patients (845‐025‐3305)
An OLCC processor may register with the commission to process for OMMP cardholders. There are limits to the amount of product received from cardholders and the amount of product that can be given back to cardholders. Processors may combine marijuana received from multiple patients and distribute the end product in proportional shares.
Processors
Processing Industrial Hemp (845‐025‐3210)
An OLCC processor may apply for an Industrial hemp endorsement in order to receive industrial hemp and hemp‐derived product from hemp growers and hemp handlers with an OLCC Industrial Hemp Certificate (see 845‐025‐2700 and 845‐025‐2750) and process the material into industrial hemp items.
4
Processors
Requirements for Processing Industrial Hemp (845‐025‐3285)
An OLCC processor with an industrial hemp endorsement may process hemp into extracts and concentrates, prior to the items being transferred or changed into a product, the processor must have the potency tested to ensure the extract or concentrate does not contain more than 5% THC.
• After testing, the item can be transferred, combined with marijuana or turned into a product.
• If combined with marijuana, the item will be considered a marijuana item and taxed accordingly
Retailers
Industrial Hemp in OLCC Retail Stores (845‐025‐2800)
Industrial hemp items sold at OLCC retail stores need to come from an OLCC processor with an endorsement to process industrial hemp. Industrial hemp items that were received from a source other than a licensee may be retained and sold until April 1, 2018.
Retail to Retail Transfer (845‐025‐2800)
Retailers who have multiple retail licenses may transfer product from one store to another if the individuals named on their license or people with financial interest in their business are identical.
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OMMP ‐ Tracking
Grow site Transfers to Wholesale and Processors (845‐025‐2130)
Medical grow sites that are tracked in CTS and meet rule criteria will be able to transfer limited quantities of usable marijuana annually to OLCC licensed processors and wholesalers. A grow site will not be eligible for transferring usable marijuana into the OLCC system until the grow site has an account in CTS beginning in the Spring of 2018. All transfers will be in CTS, just like a licensee to licensee transfer.
Grow sites will need to be approved by the OLCC and provide verification of legal access to water prior to any transfers. All transfers will come through CTS and be accompanied with a valid transfer manifest.
Changes for ODA Hemp Growers and Handlers
Hemp Certificate (845‐025‐2700 & 845‐025‐2750)
Oregon Department of Agriculture hemp growers and hemp handlers may apply for an Industrial Hemp Certificate, allowing them to transfer or sale product to an OLCC processor. Once the product is transferred or sold into the OLCC licensed system it will stay in the system until the final sale to a consumer.
Temporary Suspension (HB 4089)HB 4089 went took affect April 13, 2018. The OLCC suspended approval of hemp certificates until rulemaking is completed and HB 4089 can be implemented.
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Changes for ODA Hemp Growers and Handlers
Hemp rulemaking for HB 4089
All ODA growers and handlers with an OLCC hemp certificate, including current certificate holders, will receive information on their requirement to register for a Cannabis Tracking System (CTS) account.
Prior to the transfer of a hemp item the OLCC hemp certificate holder will need to enter the hemp item into CTS and have appropriate tests performed. Only hemp items being transferred into the OLCC system will be entered into CTS.
ODA registered hemp growers and handlers with an OLCC hemp certificate will be able to transfer: hemp, hemp commodities and/or hemp products to OLCC licensed processors, wholesalers and retailers.
OLCC Compliance
Current Compliance Inspections
Inspectors will be reviewing licensed premises for compliance with:
• Cannabis security and tracking requirements
• Compliance with basic operational requirements
• Unapproved premises alterations
• Unapproved business structure changes
•Ongoing retail licensee minor decoy operations
•Auditing CTS data for possible compliance actions
2
Common Errors
Packaging & Testing Incorrectly
• Creating large bulk Lot Packages from harvests – Larger than 15 pounds
• Pulling from the bulk Lot Package to make Child Packages
• Testing from both the bulk Lot Packages & Child Packages simultaneously
3
Packaging & Testing Incorrectly
Bulk Lot PackageBlue Dream Buds
20 lbs
Blue Dream Bud5 lbs
Test SampleBlue Dream Bud 32g
Test SampleBlue Dream Bud 13g
Testing Facility
Packaging & Testing Correctly
Bulk PackageBlue Dream Buds
30lbs
Blue Dream Buds15lbs
Blue Dream Trim15lbs
Test SampleBlue Dream Bud 13g
Test Sample Blue Dream Trim 13g
Testing Facility
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Packaging & Transferring Errors
• Creating packages while product is being tested
• Wait for ALL test results to be entered into Metrc before repackaging or transferring product
• Status of TEST PASSED OR RETEST PASSED
New Features
18
Rooms –Coming SoonProcessors, Wholesalers &
Dispensaries
Rooms – Processors, Wholesalers & Dispensaries
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Training
New and Existing Metrc Training Classes
•OR New Business Level 1
•Advanced Producer Level 2•Advanced Retailer Level 2•Advanced Processor Level 2•Advanced Wholesaler Level 2
•www.metrc.com/oregon
24
Interactive Support
‣ Interactive Support‣ E‐mail
‣ support@metrc.com
‣ Phone‣ Metrc support line ‐ 877‐566‐6506
‣ Hours: ‣M‐F 7:00am to 6:00pm PST‣Saturday 7:00am to 5pm PST‣Sunday (Check VM & Email)
www.metrc.com
1
Oregon Recreational Marijuana Program Packaging & Labeling Update
Spring 2018
Jamie Dickinson, Policy Analyst
Oregon Liquor Control Commission
What will be covered in this presentation:
Rules: What is not changing?
Product types and definitionsPackages vs. Labels
Rule Changes: What has changed?
Label examples
Changes to packaging
2
What will be covered in this presentation:
What happens now the rules have been
adopted?
Resubmission of Label Applications
Effective Dates and Sell Down Periods
What you can do to make the process faster and smoother
Definitions and Product Types – These rules have NOT changedConcentrate Means a substance obtained by separating cannabinoids
from marijuana by:
Mechanical extraction process; Chemical extraction process using a non-hydrocarbon solvent, (i.e.
water, vegetable glycerin, vegetable oils, animal fats, ethanol); or Chemical extraction process using carbon dioxide, as long as
process doesn’t use high heat or pressure; or Any other process identified by the Commission in rule.
If ANY ingredient or substance is added to the substance, it is no longer a concentrate or an extract.
3
Definitions and Product Types – These rules have NOT changedExtract Means a substance obtained by separating
cannabinoids from marijuana by: Chemical extraction process using a hydrocarbon-
based solvent, (i.e. butane, hexane, propane); Chemical extraction process using carbon dioxide
and high heat or pressure; or Any other process identified by the Commission, in
rule.
If ANY ingredient or substance is added to the substance, it is no longer a concentrate or an extract.
Definition and Product Type Example
Concentrate 1g (0.035 oz)
Cannabis Concentrate
Growing Green, LLC License Number: 1000026J04DUID 1A4018297310677118742955Product Made on 6/11/16
Suggested serving size: 0.1 gServings per container: 10THC: 6 mg/serving; 900 mg/container CBD: 10 mg/serving; 1500 mg/containerActivation Time: Immediate
DO NOT EAT. For use by adults 21 and older. Keep out of reach of children. It is illegal to drive a motor vehicle while under the influence of marijuana. This product is not approved by the FDA to treat, cure, or prevent any disease.
Lab Name, Test Date 6/20/16100006635287465212589254
1 g (0.035 oz)
This product is labeled as a concentrate and listed as a concentrate in Metrc.
Product must meet the definition of concentrate
Product must be tested as a concentrate
Product must follow the concentration limits and daily sales limit rules for concentrates
4
Definition and Product Type Example
Cannabis Concentrate
1 fl oz (30 mL)
Is there an issue with this product?
Yes. If this product is a concentrate, it exceeds the daily sales limits. The limit is 5 grams and 30 milliliters is more than 5 grams.
Retail and Wholesale licensees should NOT accept these products.
Definitions and Product Types
Edible Means food or potable liquid into which a cannabinoid
concentrate, cannabinoid extract, or dried marijuana leaves or flowers have been incorporated.
For purposes of labeling, includes any marijuana, cannabinoid concentrate, extract or cannabinoid product that is intended for human consumption or marketed in a manner that implies the item is for human consumption.
5
Definitions and Product Types
Cannabinoid Product Means a cannabinoid edible or any other product intended for
human consumption or use, including a product intended to be applied to the skin or hair; or
Usable marijuana, cannabinoid extracts and concentrates that have been combined with an added substance.
Does not include:
Usable marijuana by itself;
Cannabinoid concentrate by itself;
Cannabinoid extract by itself; or
Industrial hemp.
Cannabinoid topicals and edibles are cannabinoid products.
Flavored extracts/concentrates and infused joints are also cannabinoid products.
Definitions and Product Types
Only usable marijuana and paper/filter/cone
Product Type: Usable marijuana
Can be made by all license types, except for a processor
Must follow usable marijuana testing requirements
Pre-roll
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Definitions and Product Types
Usable marijuana and paper/filter/cone AND concentrate, extract, flavoring, or any other additional substance
Product Type: Cannabinoid product
Can ONLY be made by a processor
Must follow cannabinoid product testing requirements
Infused Pre-roll or Pre-roll with Added Substances
Is this a package or a label?
It is both. The Mylar bag is the package and the printed design is a part of the label.
7
Definitions
Package The physical structure or
container that holds the marijuana item or an outer container that is used to display the item for sale.
Multiple packages for one product can be submitted on the same application.
Label Any text, graphics, pictures, or
logos that are printed directly on the package or affixed to the package.
Different panels all count as one label.
Changes to Packaging and Labeling RulesRules adopted by OLCC Commissioners on May 17, 2018
8
NOTE: The adopted rules are not effective until August 15, 2018.
Until the new rules become effective, the old rules are still in place. Right now, you should be following the old rules.
Blue boxes indicate when the old rules are in effect.
The red circle indicates when the new rules will become effective.
Changes to Labeling Rules
What did the changes do?
Moved labeling rules from OHA to OLCC and put packaging and labeling rules in the same location (Division 25).
Added requirements for hemp labeling and a hemp symbol.
Created rules that will more closely follow FDA labeling requirements.
Provided more clarification on rules that the OLCC received questions about.
This presentation will NOT cover all rule changes.
9
Changes to the Labeling Rules Rule changes will make labels easier to read and understand
and more uniform in appearance
Product Identity
Bold type, parallel to base of container, and must identify whether product contains hemp or cannabis
Net Quantity of Contents (Net Weight or Volume)
Must be in bold type, a distinct item separated from other information, and parallel to base of container
Located in bottom 30% of principal display panel (PDP)
Pre-rolls must provide the weight of usable marijuana and the weight of the final product
Proposed Changes to the Labeling Rules Potency
Can include a target amount on PDP but also must include lab calculated value
Font
All required information can be in any legible, typed font. Must be at least 1/16 of an inch in height based on the uppercase “K”
Addition of Label Identification Number
10
Pro
duce
d by
: P
rodu
cer
Nam
e, L
ic #
100
9876
540
9P
acka
ged
by:
Who
lesa
ler
Nam
e
For
use
onl
y by
adu
lts 2
1 an
d ol
der.
Kee
p ou
t of
rea
ch o
f ch
ildre
n. I
t is
ille
gal t
o dr
ive
a m
otor
veh
icle
whi
le u
nder
the
influ
ence
of
mar
ijuan
a.
Act
ivat
ion
Tim
e: Im
med
iate
Str
ain:
Blu
e D
ream
UID
: 1A
3894
65F
5871
J09
8734
1893
Har
vest
Dat
e: 0
0/00
/00
TH
C: 0
0%,
CB
D 0
0%
Lab
Nam
eT
est D
ate:
00/
00/0
0T
est B
atch
Num
ber:
Net weight 1 g (0.035 oz)
Pre-roll
LO O
G
Pro
du
ced
by:
Pro
du
cer
Na
me,
Lic
# 10
098
7654
09
Pa
cka
ged
by:
Who
lesa
ler
Na
me
Stra
in: B
lue
Dre
am
Lab
el ID
: 137
84
For use only by adults 21 and older. Keep out of reach of children. Do not
drive a motor vehicle while under the influence of marijuana.
UID
: 1A
3894
65F5
871J0
9873
4189
3H
arv
est
Da
te: 0
0/0
0/0
0La
b N
am
eTe
st D
ate
: 00
/00
/00
:
Net weight 1 g (0.035 oz)
Cannabis Pre-roll
LO O
G
Current Rules New Rules
Usable Marijuana Label Changes
Font: any readable font at least 1/16 inch based on an uppercase “K.”
Net weight: in bold font , parallel to base of package, and free from other information
Product identity: in bold font, identify item as marijuana, and be parallel to base of container
Label identification number
THC: 00%, CBD 00%
Flower weight: 700 mg Weight of the usable marijuana in pre-roll
Current Rules for Edible Products
Front Back
Net wt 1 g(0.035 oz)
5 Oatmeal Cookies
Processor Name, Lic # 10087D385941234 Main Street, Portland, OR 97222
Distributed by: Wholesaler2564 North Street, Portland, OR 97222
Serving: 1 Cookie Servings per Container: 5Ingredients: Sugar, Whole Wheat Flour, Malted Barley Flour, Butter, Palm Oil, Rolled Oats, Egg, Coconut, Sugar, Baking Soda, SaltContains: Wheat, Milk, Egg, CoconutSodium 150mg, Sugar 20g, Total Carbohydrates 38g, Total Fat 9gUID: 1A8950689836D4869097G786Made: 00/00/00THC: 5mg/serving; 25 mg/containerCBD: 3 mg/serving; 15 mg/containerActivation Time: 30 minutesLab Name, Tested: 00/00/00, Test Batch Number: 00000000-0000For use only by adults 21 and older. Keep out of reach of children. It is illegal to drive a motor vehicle while under the influence of marijuana.BE CAUTIOUS Cannabinoid edibles can take up to 2 hours or more to take effect. This product is not approved by the FDA to treat, cure, or prevent any disease.
11
New Rules for Edible Product
Front Back
Net wt 1 g(0.035 oz)
5 Cannabis Oatmeal Cookies
Processor Name, Lic # 10087D385941234 Main Street, Portland, OR 97222
Distributed by: Wholesaler2564 North Street, Portland, OR 97222
For use only by adults 21 and older. Keep out of reach of children. Do not drive a motor vehicle while
under the influence of marijuana.
BE CAUTIOUS Cannabinoid edibles can take up to 2 hours or more to take effect. This product is not approved by the FDA to treat, cure, or prevent any
disease.
UID:1A8950689836D4869097G786
THC: 4 mg/serving; 20 mg/container
CBD: 2 mg/serving; 10 mg/container
Made: 00/00/00
Lab NameTest Date: 00/00/00
Activation time required
Nutrition Information, serving size, number of servings, ingredients, and potential allergens must be in table format provided by OLCC
Net weight: bold, parallel to base, and free from other information
Font: any readable font that is at least 1/16 inch based on an uppercase “K.”
Product identity: bold, identify item as marijuana, and be parallel to base of container
THC: 5mg/serv ;25/pkgCBD: 3mg/serv; 15/pkg
Target potency with 10% variance allowed on PDP
Actual potency lab value must be included
Potential Variations of Nutrition Facts Information
Horizontal Option
Small Container Option Vertical Option
12
Current Rules for Tincture Product
1 mL (0.034 fl oz)
Serving Size: 3 drops; Servings per Bottle: 30Ingredients: Water, ethanol, cannabis extract
UID: 1A8950689836D4869097G786Made: 00/00/00
THC: 5mg/serving; 25 mg/containerCBD: 3 mg/serving; 15 mg/container
Activation Time: 30 minutes
Lab Name, Tested: 00/00/00, Test Batch Number: 00000000-0000
For use only by adults 21 and older. Keep out of reach of children. It is illegal to drive a motor vehicle while under the influence of marijuana. This product is not approved by
the FDA to treat, cure, or prevent any disease.
Processor Name, Lic # 10087D385941234 Main Street, Portland, OR 97222
Distributed by: Wholesaler2564 North Street, Portland, OR 97222
Tincture
Current rule only allows for tinctures containing alcohol. The rule changes the definition to allow other types of tincture products and limits container size to 4 fluid ounces.
Proposed Rules for Tincture Product
1 mL (0.034 fl oz)
Activation Time: 30 minutesServing Size: 3 drops; Servings per Bottle: 30
Ingredients: Water, ethanol (27%), cannabis extract
UID: 1A8950689836D4869097G786; Made: 00/00/00; Lab Name, Date Tested: 00/00/00
Per Serving: 9 mg THC; 4 mg CBDBottle: 270 mg THC; 120 mg CBD
For use only by adults 21 and older. Keep out of reach of children. Do not drive a motor
vehicle while under the influence of marijuana. This product is not approved by the FDA to
treat, cure, or prevent any disease. BE CAUTIOUS Cannabinoid products can take
up to 2 hours or more to take effect
Processor Name, Lic # 10087D385941234 Main Street, Portland, OR 97222
Distributed by: Wholesaler2564 North Street, Portland, OR 97222
Cannabis Tincture
THC: 10mg/serving; 300 mg/containerCBD: 3 mg/serving; 90 mg/container
Activation time required
Net weight: bold, parallel to base of package, and free from other information
Font: any readable font that is at least 1/16 inch based on a uppercase “K.”
Product identity must be in bold, identify item as marijuana, and be parallel to base of container
Target potency on PDP (not required)
Actual potency required
Alcohol tinctures must contain at least 25% alcohol
13
Changes to the Labeling Rules
Small Container Label – for packages too small to carry a full label
Universal symbol, net weight, and product identity;
Business name and license number;
UID number;
Total THC and CBD; and
A warning that reads: “For use only by adults 21 and older. Keep out of reach of children.”
New Rules add a new labeling scheme for very small packages
Changes to the Labeling Rules
Tiny Container Label – for packages with a surface area less than two inches squared.
The universal symbol and product identity;
Business name and license number;
UID number;
Total THC and CBD; and
A warning that reads: “Keep out of reach of children.”
New Rules add a new labeling scheme for very small packages
14
Tiny Container vs. Small Container Labels
ExtractKeep out of reach of
children.
ABC
Pro
cess
or,
1006
54E4
521
1A38
4760
F456
2314
5879
6548
235
6 m
g C
BD,
23 m
g TH
C
For
use
only
by
adul
ts 2
1 an
d ol
der.
CBD Tincture
Keep out of reach of children.
1 fl oz (30 mL)
Label examples are not to scale but meant to illustrate the differences.
Changes to Packaging Rules
Non-child resistant packages will no longer require approval. Non-child resistant packages must include the following statement: “This package is not child resistant” on the label.
Child resistant packages must still be tested and certified by qualified third-party company.
Hemp products must follow same rules as marijuana and must leave the store in child resistant packages.
This presentation will NOT cover all rule changes.
15
Examples
These packages do not need to be submitted for package approval.
Do not need package approval but MUST be submitted for labelapproval even if using a plain label.
Plain, non-child resistant packages Non-child resistant packages with graphics or designs printed on them
What happens next?
16
Effective Dates
May 17, 2018 - Rules adopted at May Commission Meeting. However, the old rules are still in effect at this time. Applications continue to be reviewed under old rules.
August 15, 2018 – Adopted rules become effective. All applications received on or after this date will be reviewed under the new rules.
April 1, 2019 – All marijuana items and hemp commodities and products packaged or transferred for sale to a consumer must follow new rules. Products packaged and labeled under old rules can still be sold in retail stores.
January 1, 2020 – All items must be packaged and labeled under new rules. Until this date, items labeled under the old rules can continue to be sold. On and after this date, all products must be compliant with new rules.
May 17, 2018 – New rules adopted
August 15, 2018 – New rules effective
April 1, 2019 – All products made and transferred between licensees must follow new rules
January 1, 2020 – All products sold must follow new rules
17
Changes to Your Packaging and Labeling Dashboard Your Application Status Will Change
All label applications that were previously approved will have the application status automatically change to “Resubmission Required.” The status change will likely occur in early August 2018.
You will need to Resubmit the Application with Label Changes
You will need to update the label according to the newly adopted rules and resubmit it under the same application.
To save time and money, if you are planning to make changes to your label, you may want to wait until after the new rules go into effect.
Changes to the Preapproval Process
Beginning July 1, 2018:
1. All applications submitted will be given two chances to submit a compliant application as described in OAR 845-025-7060. If the second submission is not compliant with the rules, the application will be denied and you must apply again
2. Before an application can be changed or updated, you will need to pay the $25 fee application fee. The fee amount is specified in OAR 845-025-1060.
18
Improving the ProcessWhat can you do to make the packaging and labeling process faster and smoother?
What can you do to make the process better?
READ THE RULES AGAIN Take advantage of the guides and
information on the website.
THE RULESREAD
19
What can you do to make the process better? Double-check your label with the checklist BEFORE
submitting.
Label Checklist
Blue DreamImmature Plant
Growing Gardens, LLC 10098738F78
20
What can you do to make the process better? Double-check your label with the checklist BEFORE
submitting.
Make sure you are providing only information relevant to the package or label you are submitting for approval
Submit enough information so the reviewer can understand where the labels go on the package and how your package looks as a final product
Name the image files with an appropriate description
Remove non-compliant images before resubmitting
QUESTIONS???
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